TherapeuticsMD, Inc. 8-K 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

 

TherapeuticsMD Announces Fourth Quarter and Full Year 2015 Financial Results

 

– Company to Present additional positive phase 3 data for TX-004HR at the ISSWSH annual meeting –

 

– Management to host conference call today at 4:30 p.m. EST –

 

BOCA RATON, Fla. February 25, 2016 TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced its fourth quarter and full year financial results for 2015.

 

2015 and Recent Developments

 

·Net revenue for the company’s prescription prenatal vitamin business increased to approximately $20.1 million in 2015 compared with approximately $15.0 million for the prior year.
·Net loss was approximately $85.1 million in 2015, compared with approximately $54.2 million for the prior year, reflecting investment in two phase 3 clinical trials for the company’s novel hormone therapy drug candidates.
·Reported positive topline data from the Rejoice Trial, a phase 3 clinical trial of TX-004HR, an applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The results showed patients treated with TX-004HR achieved a statistically significant improvement over placebo across all four co-primary endpoints at all three doses evaluated. The validated co-primary endpoint data and additional secondary endpoint results related to vaginal dryness are scheduled to be presented this week at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting 2016. A summary of these data is included below in this press release.
·Exited over 1,400 of the 1,750 patients enrolled in the Replenish Trial, a phase 3 clinical trial of TX-001HR, a combination estradiol and progesterone drug candidate, for the treatment of moderate to severe vasomotor symptoms due to menopause. Topline results are currently anticipated late in the fourth quarter of 2016.
·The company’s intellectual property portfolio grew to a current total of 122 patent filings, including 72 international filings, with one allowed and 14 issued U.S. patents.
·Presented two posters at North American Menopause Society (NAMS) of the company’s transdermal progesterone candidate, TX-005HR, and the company’s transdermal estradiol and progesterone candidate, TX-006HR, demonstrating tissue penetration and target organ activity in a preclinical study.
·Strengthened relationships with key medical, pharmacy, patient and industry organizations worldwide.
·Ended the year with approximately $64.7 million in cash and no debt, which was further strengthened by an equity offering in January 2016 that generated approximately $135 million of net proceeds to fund commercialization activities for both of the company’s late stage product candidates and other development activities.

 

“2015 was a breakthrough year for our company, as we reported positive topline phase 3 data from the Rejoice Trial for TX-004HR, the first of our two novel pipeline candidates in the women’s health arena,” said TherapeuticsMD CEO Robert G. Finizio. “Based on those compelling results, we are preparing to file an NDA before June 30, while we also expect topline data late in the fourth quarter of 2016 from our Replenish Trial for TX-001HR. We believe we are well positioned from a financial, clinical and commercial standpoint to execute on our goals in 2016 and create significant value for shareholders by advancing our pipeline and preparing to launch our first novel hormone product for women, if approved.”

 

Summary of 2015 Financial Results

 

For the year ended December 31, 2015, net revenue increased approximately 34 percent to approximately $20.1 million compared with approximately $15.0 million for the prior year. Net revenue for the fourth quarter of 2015 was approximately $5.6 million compared with net revenue of approximately $4.3 million for the prior year’s quarter. Revenue growth during the fourth quarter was primarily driven by a change in product mix and an increase in the average net sales price of the company’s prenatal vitamin products and revenue growth during the full year was primarily driven by an increase in the number of units sold and an increase in the average sales price of the company’s prenatal vitamin products.

 

Cost of goods sold increased to approximately $4.5 million for the full year 2015, compared with approximately $3.7 million in the prior year.

 

Total operating expenses for the fourth quarter and full year 2015 included research and development (R&D) expenses and sales, general and administrative expenses (SG&A). R&D expenses for the full-year 2015 were approximately $72.0 million compared with approximately $43.2 million for the prior year, primarily as a result of an increase in costs related to the company’s phase 3 clinical trials for TX-001HR and TX-004HR and an increase in scale-up and manufacturing activities primarily related to TX-001HR. R&D expenses during the fourth quarter of 2015 were $13.3 million compared to $14.2 million during the prior year’s quarter, reflecting a significant decline in the company’s clinical trial costs, partially offset by an increase in scale-up and manufacturing activities to support commercialization. SG&A expenses for the full-year 2015 were approximately $28.7 million compared with approximately $22.1 million for the prior year, reflecting an increase in human resources related costs, increased consulting and professional costs, increased insurance cost and increased sales and marketing expenses. SG&A expenses for the fourth quarter of 2015 were approximately $8.6 million compared with approximately $5.5 million for the prior year’s quarter, primarily as a result of increased human resource related costs, as well as increased sales and marketing and office expenses.

 

Non-operating income remained insignificant for the full year 2015 and 2014 and included interest income and other miscellaneous items of income and expense for both periods.

 

Net loss for the full year 2015 was approximately $85.1 million, or $0.49 per basic and diluted share, compared with approximately $54.2 million, or $0.36 per basic and diluted share, for the full year 2014. Net loss in the fourth quarter of 2015 was approximately $17.5 million, or $0.10 per basic and diluted share, compared with approximately $16.3 million, or $0.10 per basic and diluted share, for the fourth quarter of 2014.

 

At December 31, 2015, cash on hand was approximately $64.7 million, compared with approximately $51.4 million at December 31, 2014.

 

 

 

 

Phase 3 Data Results Presented at ISSWSH Annual Meeting 2016

 

TherapeuticsMD also announced that data from the phase 3 Rejoice Trial would be presented at the ISSWSH Annual Meeting 2016 taking place February 25-28 in Charleston, South Carolina. The poster to be presented includes validated co-primary endpoint results from the Rejoice Trial and secondary endpoint data that demonstrate the effect of TX-004HR on severity of vaginal dryness as compared with placebo at week 12.

 

Based on the company’s ongoing analyses of the Rejoice Trial data, statistical significance of the results for the co-primary endpoint of severity of participants' self-reported moderate to severe dyspareunia as the most bothersome symptom of VVA has slightly improved for all three doses from the topline results previously reported. The secondary endpoint result for vaginal dryness was also statistically significant for all three doses evaluated in the Rejoice Trial.

 

Statistical Significance of Results for Co-Primary Endpoints
(Based on LS Mean Change from Baseline to Week 12 Compared to Placebo)

 

   25 mcg  10mcg  4 mcg
 Superficial Cells   

P < 0.0001

    

P < 0.0001

    

P < 0.0001

 
 Parabasal cells   

P < 0.0001

    

P < 0.0001

    

P < 0.0001

 
 Vaginal pH   

P < 0.0001

    

P < 0.0001

    

P < 0.0001

 
 Severity of Dyspareunia   

P < 0.0001

    

P < 0.0001

    

P = 0.0149

 

 

 

 Statistical Significance of Results for Secondary Endpoint of Severity of Vaginal Dryness
(Based on LS Mean Change from Baseline to Week 12 Compared to Placebo)

 

 

 Severity of Dryness   

P < 0.0001

    

P < 0.0001

    

P = 0.0014

 
LS= Least Squares               

 

Conference Call Today

 

As previously announced, TherapeuticsMD will host a conference call today to discuss these financial results and provide a business update. Details for the call are:

 

Date: Thursday, February 25, 2016
Time: 4:30 p.m. EST
Telephone Access (US): 866-665-9531
Telephone Access (International): 724-987-6977
Access Code for All Callers: 45870409

 

Additionally, a live webcast can be accessed on the company’s website, www.therapeuticsmd.com, on the Home Page or under the “Investors & Media” section. A digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 45870409.

 

About TherapeuticsMD, Inc.

 

TherapeuticsMD, Inc. is an innovative healthcare company focused on developing and commercializing products exclusively for women. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. The company’s clinical development pipeline includes two phase 3 products. The company also manufactures and distributes branded and generic prescription prenatal vitamins as well as over-the-counter vitamins under the vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites: www.therapeuticsmd.com, www.vitamedmd.com, www.vitamedmdrx.com and www.bocagreenmd.com.

 

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize its hormone therapy drug candidates and obtain additional financing necessary therefor; the length, cost and uncertain results of the company’s clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company’s hormone therapy drug candidates; the company’s reliance on third parties to conduct its clinical trials, research and development and manufacturing; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. PDF copies of the company’s historical press releases and financial tables can be viewed and downloaded at its website: www.therapeuticsmd.com/pressreleases.aspx.

 

# # #

 

Contacts

 

Investors:

Dan Cartwright
Chief Financial Officer

561-961-1900

Dan.Cartwright@TherapeuticsMD.com

 

 

 

   

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS

               
    December 31,  
    2015   2014  
ASSETS  
Current Assets:              
Cash   $ 64,706,355   $ 51,361,607  
Accounts receivable, net of allowance for doubtful accounts of $81,910 and $59,753, respectively     3,049,715     2,154,217  
Inventory     690,153     1,182,113  
Other current assets     2,233,897     1,537,407  
Total current assets     70,680,120     56,235,344  
               
Fixed assets, net     198,592     63,293  
               
Other Assets:              
Intangible assets, net     1,615,251     1,228,588  
Prepaid expense     1,109,883     1,427,263  
Security deposit     125,000     125,000  
Total other assets     2,850,134     2,780,851  
Total assets   $ 73,728,846   $ 59,079,488  
               
LIABILITIES AND STOCKHOLDERS’ EQUITY  
Current Liabilities:              
Accounts payable   $ 3,126,174   $ 6,327,129  
Other current liabilities     7,539,526     3,840,639  
Deferred revenue         522,613  
Total current liabilities     10,665,700     10,690,381  
               
Commitments and Contingencies - See Note 14              
               
Stockholders’ Equity:              
Preferred stock - par value $0.001; 10,000,000 shares authorized; no shares issued and outstanding          
Common stock - par value $0.001; 350,000,000 and 250,000,000 shares authorized; 177,928,041 and 156,097,019 issued and outstanding, respectively     177,928     156,097  
Additional paid-in capital     282,712,078     182,982,846  
Accumulated deficit     (219,826,860 )   (134,749,836 )
Total stockholders’ equity     63,063,146     48,389,107  
Total liabilities and stockholders’ equity   $ 73,728,846   $ 59,079,488  

 

 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF OPERATIONS 

 
   Three Months Ended December 31,  Year Ended December 31,
                
   2015    2014    2015    2014    2013  
                          
Revenues, net  $5,629,740   $4,257,647   $20,142,898   $15,026,219   $8,775,598 
                          
Cost of goods sold   1,235,978    879,535    4,506,673    3,671,803    1,959,597 
                          
Gross profit   4,393,762    3,378,112    15,636,225    11,354,416    6,816,001 
                          
Operating expenses:                         
Sales, general, and administrative   8,631,238    5,514,057    28,721,236    22,124,072    19,014,837 
Research and development   13,253,472    14,166,789    72,042,774    43,218,938    13,551,263 
Depreciation and amortization   18,000    12,558    62,400    52,467    58,145 
                          
     Total operating expenses   21,902,710    19,693,404    100,826,410    65,395,477    32,624,245 
                          
Operating loss   (17,508,948)   (16,315,292)   (85,190,185)   (54,041,061)   (25,808,244)
                          
Other income and (expenses)                         
Miscellaneous income, net   23,991    3,158    95,719    46,569    34,544 
Interest income   2,280    9,553    17,442    37,309    27,234 
Financing costs             —      (260,027)   (1,503,922)
Interest expense            —      —      (1,165,981)
Loan guaranty costs             —      —      (2,944)
     Total other income (expense)   26,271    12,711    113,161    (176,149)   (2,611,069)
                          
Loss before income taxes   (17,482,677)   (16,302,581)   (85,077,024)   (54,217,210)   (28,419,313)
                          
Provision for income taxes   —      —      —      —      —   
                          
Net loss  $(17,482,677)  $(16,302,581)  $(85,077,024)  $(54,217,210)  $(28,419,313)
                          
Loss per share, basic and diluted:                         
                          
Net loss per share, basic and diluted  $(0.10)  $(0.10)  $(0.49)  $(0.36)  $(0.22)
                          
Weighted average number of common shares outstanding,
basic and diluted
  $177,876,462   $156,054,938   $173,174,229   $149,727,228   $127,569,731

 

 

 

 

 

THERAPEUTICSMD, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS

                     
    Year Ended December, 31,  
    2015   2014   2013  
                     
CASH FLOWS FROM OPERATING ACTIVITIES                    
Net loss   $ (85,077,024 ) $ (54,217,210 ) $ (28,419,313 )
Adjustments to reconcile net loss to net cash used in operating activities:                    
Depreciation     29,959     28,987     47,883  
Amortization of intangible assets     32,441     23,480     10,262  
Provision for (recovery of) doubtful accounts     22,157     (5,436 )   (15,493 )
Amortization of debt discount             1,102,680  
Share-based compensation     7,189,699     4,970,312     3,844,155  
Amortization of deferred financing costs         260,027     1,451,934  
Loan guaranty costs             2,944  
Changes in operating assets and liabilities:                    
Accounts receivable     (917,656 )   (458,028 )   (1,068,619 )
Inventory     491,960     (138,495 )   571,592  
Other current assets     (773,532 )   680,281     (1,386,319 )
Other assets     (17,442 )   (37,309 )   (565,706 )
Accounts payable     (3,200,955 )   4,212,912     472,851  
Deferred revenue     (522,613 )   (1,079,967 )   457,828  
Other current liabilities     3,698,887     239,450     2,875,320  
Other liabilities             (150,068 )
                     
Net cash used in operating activities     (79,044,119 )   (45,520,996 )   (20,768,069 )
                     
CASH FLOWS FROM INVESTING ACTIVITIES                    
Patent costs     (419,104 )   (586,480 )   (439,034 )
Purchase of fixed assets     (165,257 )   (30,962 )   (40,790 )
Refund (payment) of security deposit         10,686     (103,737 )
                     
Net cash used in investing activities     (584,361 )   (606,756 )   (583,561 )
                     
CASH FLOWS FROM FINANCING ACTIVITIES                    
Proceeds from sale of common stock, net of costs     91,374,649     42,771,353     78,650,353  
Proceeds from exercise of options     1,232,579     345,746     30,910  
Proceeds from exercise of warrants     366,000     181,000      
Proceeds bank line of credit             500,000  
Repayment of bank line of credit             (500,000 )
Repayment of notes payable             (4,691,847 )
                     
Net cash provided by financing activities     92,973,228     43,298,099     73,989,416  
                     
Increase (decrease) in cash     13,344,748     (2,829,653 )   52,637,786  
Cash, beginning of period     51,361,607     54,191,260     1,553,474  
Cash, end of period   $ 64,706,355   $ 51,361,607   $ 54,191,260  
                     
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:  
   
Cash paid for interest   $   $   $ 212,853  
Cash paid for income taxes   $   $   $  
   
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING ACTIVITIES:  
   
Warrants issued for financing   $   $   $ 1,711,956  
Warrants issued for services   $   $   $ 462,196  

 

   

 

 

 


The following information was filed by Therapeuticsmd, Inc. (TXMD) on Thursday, February 25, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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